BASEL, Switzerland and BRIDGEWATER, N.J., Nov. 17, 2006 (PRIMEZONE) -- Speedel (SWX:SPPN) today announced that it is very pleased with the Phase II clinical data on SPP200 in the treatment of 127 patients on chronic haemodialysis presented today at the annual meeting of The American Society of Nephrology (ASN) in San Diego. The data(1) demonstrated the robust efficacy and the good safety profile of SPP200 (pegmusirudin) which is a long-acting direct thrombin inhibitor designed to prevent the formation of clots in vascular grafts.
Dr. Jessica Mann, Medical Director, commented: "Vascular graft occlusions (VGOs) represent a large unmet medical need. The cost of graft replacement and maintenance of potency is estimated to be more than USD 700 million annually in the US(2). With these positive Phase II results SPP200 is clearly highlighted as an effective new anti-coagulant therapy to decrease the frequency of VGOs, as well as extending the time to the first VGO. We believe SPP200 could significantly improve the standard of care of patients on haemodialysis."
The ASN meeting in San Diego is the first time that data on SPP200 has been presented by Speedel in a scientific forum. Vascular graft occlusion occurs in patients when a clot forms in the graft connecting a patient to the dialysis machine. The study compared the safety and efficacy profile of SPP200 to that of unfractionated heparin (UFH) which, in the U.S., is the gold standard anti-coagulant in haemodialysis. 127 patients were observed in up to 108 haemodialysis sessions each, and the Phase ll data from a total of over 9,000 dialysis sessions show that:
-- The frequency of VGOs was significantly lower with SPP200 (17.3%)
than with UFH (43.2%) (p=0.004)
-- The probability of patients having a VGO was approximately three
times less when treated with SPP200 compared to UFH
-- Graft survival curves indicated that by the end of treatment
fewer patients on SPP200 (20%) had VGOs compared to the UFH group
(50%)
-- Major bleeding events were rare with either SPP200 (8.4% for all
doses, 3.6% for the lower dose) or with UFH (5.4%)
-- The mean frequency of minor bleeding events was 2.57% for SPP200
compared to 0.80% for UFH (number of minor bleeding events per
100 haemodialysis sessions, p less than 0.001)
The Phase ll trial in the U.S. studied 127 patients on haemodialysis through a PTFE(3) graft in a randomized, open-label study, with a 2:1 randomization favoring SPP200. Patients on UFH followed the standard treatment at site. The SPP200 dose was calculated based on post-dialysis activated partial thromboplastin time (aPTT) of the prior session. Several different doses of SPP200 were investigated. At the end of the 6-month treatment period, patients were crossed over to UFH for 2 more months resulting in a total of up to 108 haemodialysis sessions per patient. In summary, further dose adjustments should be considered to better address the frequency of bleeding events, which were primarily minor in severity.
About SPP200
SPP200 (pegmusirudin), a pegylated recombinant protein, is a long-acting direct thrombin inhibitor. Patients on chronic haemodialysis must generally be connected to a dialysis machine via a graft several times a week. Maintenance of the graft is one of the most challenging problems. Anti-coagulants are given to reduce clotting during dialysis sessions, but despite these precautions the grafts still have a clotting rate of 30-65% per year. According to the U.S. Renal Data System, the cost of graft replacement and maintenance of vascular access is estimated to be more than USD 700 million annually in the U.S.
SPP200 is designed to prevent clot formation in the graft. It has a long duration of action (half life between 59-160 hours) and is not removed from the patient's body during dialysis, unlike unfractionated heparin which in the U.S. is the gold standard anti-coagulant in haemodialysis. Speedel believes that these properties of SPP200 are unique and have the potential to protect these patients from clotting events both during and between dialysis sessions. SPP200 therefore offers potential for reducing the frequency of graft replacements necessitated by these clotting events.
It is estimated that the end-stage renal disease (ESRD) population in the U.S. was approximately 400,000 in 2000 and forecasts indicate that this number will exceed 600,000 in 2010 and 2 million in 2030. More than 300,000 patients with ESRD were on chronic haemodialysis in the U.S. in 2003. Based on Decision Resources Data, Speedel estimates that the number of haemodialysis patients exceeds 250,000 in the five major European markets (Germany, France, United Kingdom, Italy, Spain) and there are approximately 200,000 haemodialysis patients in Japan. Diabetes and hypertension are the main causes for the growth of this patient population.
SPP200 was in-licensed in 2003 from Abbott Laboratories who acquired the product through the acquisition of Knoll AG in 2002. In Q3 2006, for strategic portfolio considerations, Abbott decided not to exercise their call back option on the product. Based on these promising results from the Phase II trial, Speedel is evaluating all options for further development of this product.
About Speedel
Speedel is a public biopharmaceutical company that seeks to create value for patients, partners and investors by developing innovative therapies for cardiovascular and metabolic diseases. Speedel is a world leader in renin inhibition, a promising new approach with significant potential for treating cardiovascular diseases. Our lead compound SPP100 (Aliskiren, Tekturna(4)), the first-in-class renin inhibitor, is partnered with Novartis for development and commercialisation in hypertension; SPP100 was filed with the FDA in the U.S. in Q1 2006 and with the EMEA in the EU in Q3 2006. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase III, SPP200 in Phase II, SPP635 in Phase Il, and several pre-clinical projects.
Speedel develops novel product candidates through focused innovation and smart drug development from lead identification to the end of Phase II. We either partner with big pharma for Phase III and commercialisation in primary-care indications, or we may ourselves complete Phase III development in specialist indications. Candidate compounds for development and the company's intellectual property come from our late-stage research unit Speedel Experimenta and from in-licensing. Our team of approximately 70 employees, including over 30 experienced pharmaceutical scientists, is located at our headquarters and laboratories in Basel, Switzerland and at offices in New Jersey, USA and Tokyo, Japan.
In March 2006 the company raised gross proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m) through the public offering of 500,000 treasury shares. As a private company, we have previously raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 183 million) from private placements of equity securities and two convertible loans and we have had total revenues, principally from milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 44 million). The company's shares were listed in September 2005 on the SWX Swiss Exchange under the symbol SPPN.
Forward-looking statements
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(1) pegmusirudin (SPP200) Effectively Decreases Vascular Graft Occlusions in Patients on Chronic Haemodialysis Poster F-PO769 http://www.abstracts2view.com/asn/
(2) U.S. Renal Data System, USRDS 2004 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD 2004
(3) polytetrafluoroethylene
(4) Tekturna (SPP100, Aliskiren) is a Novartis trade name